Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085631
Status:
TERMINATED
Last Update Posted:
2013-09-17
First Post:
2004-06-10
Brief Title:
Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer
Sponsor:
Mark Dewhirst
Organization:
Duke University
Study Overview
Official Title:
An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed because of slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer
PURPOSE This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer
PURPOSE This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer
Detailed Description:
OBJECTIVES
Compare local control failure-free survival and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone versus cisplatin and radiotherapy with hyperthermia
OUTLINE
This is a randomized multicenter study Patients are stratified according to participating center disease stage IIB or IIIA vs IIIB or IVA and age 60 years vs 60 years Patients are randomized to 1 of 2 treatment arms
LIMITATIONS
There are integrity issues with the currently available data involving international institutions in that several pieces of information relating to patient accrual and outcomes cannot be verified Therefore it would be inappropriate to report outcome measures for this study Baseline measures of age and gender are reported for the entire study cohort Participant flow is reported by treatment arm assignment which was available for a majority of patients in the currently available data Adverse events are reported for the entire cohort as some adverse events could not be classified within a particular treatment arm
Compare local control failure-free survival and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone versus cisplatin and radiotherapy with hyperthermia
OUTLINE
This is a randomized multicenter study Patients are stratified according to participating center disease stage IIB or IIIA vs IIIB or IVA and age 60 years vs 60 years Patients are randomized to 1 of 2 treatment arms
LIMITATIONS
There are integrity issues with the currently available data involving international institutions in that several pieces of information relating to patient accrual and outcomes cannot be verified Therefore it would be inappropriate to report outcome measures for this study Baseline measures of age and gender are reported for the entire study cohort Participant flow is reported by treatment arm assignment which was available for a majority of patients in the currently available data Adverse events are reported for the entire cohort as some adverse events could not be classified within a particular treatment arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000370860 | OTHER | National Cancer Institute | None |
| DUMC-4516 | OTHER | None | None |